DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings were received on March 27, 2024. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to claim 7 the term “bulb-like” renders the claim indefinite. It is unclear what is intended to be encompassed by said term, or how a section of the sleeve could be “bulb-like”.
With respect to claim 11 it is unclear by what applicant is intended to convey with the recitation “the container has a dispense opening a spout.” For the purpose of examination, the examiner will interpret this limitation to mean that the dispense opening is intended to take the form of a spout, but clarification is requested.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 6, 8-10, 12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tobin et al (USP 3,792,699).
With respect to claim 1 Tobin discloses a test arrangement (unit 10) for the detection of a substance, the test arrangement comprising a plastic sleeve (flexible wall sealed housing 14, See Col. 2, lines 63-65 for discussion of the housing being plastic), an ampule (ampoule 15) which holds a test liquid (transport medium 16) and which is disposed in the plastic sleeve (See Fig. 1), a container (enclosure 13) having a mixing space (interior of the enclosure) for holding and for mixing the test liquid and the substance, an activation element (physician described as squeezing the flexible housing 14 to break the wall of the ampoule 15, See Col. 4, lines 3-7) whose actuation causes a breaking open of the ampule so the test liquid is released to the mixing space, and a test swab (swab 11) for being immersed in the mixing space (See Fig. 1 and Col. 2, lines 40-56).
With respect to claim 3 Tobin discloses that the container is connected in a detachable manner to the plastic sleeve (See Col. 3, lines 64-66 for discussion of the cap being pulled off the enclosure) and the mixing space of the container is connected via a transfer opening (port 25, See Col. 4, lines 3-7) to a holding area (space between ampoule 15 and sleeve 14 wall) of the plastic sleeve, in which the ampule is disposed (See Fig. 1).
With respect to claim 4 Tobin depicts that the transfer opening is formed on the plastic sleeve (See Col. 2, lines 60-63).
With respect to claim 6 Tobin discloses that the activation element comprises defined pressure areas of the plastic sleeve (physician described as squeezing the flexible housing 14 to break the wall of the ampoule 15, See Col. 4, lines 3-7; walls of the housing are being interpreted as being the defined pressure areas of the plastic sleeve).
With respect to claim 8 Tobin discloses that the container has a base (closed open end 30, See Fig. 1 and Col. 3, lines 25-30).
With respect to claim 9 Tobin discloses that container has a dispense opening (open end 31 of enclosure 13, See Fig. 1 and Col. 3, lines 25-30).
With respect to claim 10 Tobin discloses that the dispense opening is equipped with a manually detachable cap (cap 12; See Fig. 1 and Col. 3, lines 64-66 for discussion of the cap can be removed from the enclosure).
With respect to claim 12 Tobin depicts that the plastic sleeve has an apron (annular flange 27, See Fig. 1), which encloses the container (See Col. 3, lines 3-8 for discussion of how the flange 27 and surface 6 of the top wall of the cap can be fused together, which would effective close the top end of the container).
With respect to claim 14 applicant should note these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Tobin and the apparatus of Tobin is capable of the recitation of claim 14. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Tobin (see MPEP §2114).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 11, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannis et al (US 2016/0116379 A1).
With respect to claim 1 Hannis discloses, in one embodiment, a test arrangement (apparatus 100, See Fig. 1A and Para. 0069) for the detection of a substance, the test arrangement comprising a plastic sleeve (hollow main body 110, See Para. 0069; plastic material discussed in Para. 0072), a chamber (120/220, See Para. 0069 and 0077) which holds a test liquid (See Paras. 0069 and 0074 for discussion of fluid being released from chamber 120) and which is disposed in the plastic sleeve (See Para. 0075), a container (swab housing 160, See Para. 0069) having a mixing space (interior of swab housing that holds the swab, See Para. 0107) for holding and for mixing the test liquid and the substance, an activation element (puncturing element 270, See Para. 0086) whose actuation causes a breaking open of the chamber (120) so the test liquid is released to the mixing space, and a test swab (swab 160) for being immersed in the mixing space (See Para. 0069 and Fig. 4).
The current embodiment of Hannis fails to disclose the incorporation of an ampoule arranged in the plastic sleeve.
Para. 0108 of Hannis teaches that the chamber is a fractionable ampoule. In such embodiments, upon securing of the hollow main body with the hollow applicator body in a stand-by position, application of a distal force to the hollow main body results in contact between the fractionable ampoule and the puncturing element which results in a “breaking” of the fractionable ampoule thereby releasing its contents (e.g., fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the ampoule of the alternative embodiment in place of the chamber of Hannis as a fractionable ampoule has been discovered to be a viable alternative to a puncturable chamber (See Para. 0108 of Hannis).
With respect to claim 11 Hannis depicts that the container has a dispense opening in the form of a spout (See Fig. 4 for depiction of the opening that the swab 150 is inserted into; it is being interpreted that this opening would qualify as a spout).
With respect to claim 14 applicant should note these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Hannis and the apparatus of Hannis is capable of the recitation of claim 14. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Hannis (see MPEP §2114).
With respect to claim 15 Hannis discloses the incorporation of a shaft receptacle (open channel 140, See Fig. 3 and Paras. 0094-0098; Para. 0106 discusses that the open channel is configured to releasably secured with the swab housing, wherein the open channel proximal end connects with an opening within the swab housing). Fig. 4, step 4 seems to depict that the swab is engaged with the hollow main body 110, but applicant should note that the swab being inserted in a shaft receptacle is being interpreted as being directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Hannis and the apparatus of Hannis is capable of the recitation of claim 15. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Hannis (see MPEP §2114).
Claim(s) 2 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tobin et al (USP 3,792,699).
With respect to claim 2, Tobin fails to disclose that the plastic sleeve and the container are formed by a one-piece construction. However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to make the plastic sleeve and the container integral, since it has been held that forming in one piece a structure which has formerly been formed in two, or more pieces, involves only routine skill in the art.
With respect to claim 7, although Tobin depicts hat the plastic sleeve has a cylindrical shape, Tobin fails to disclose that the plastic sleeve comprises a section in the shape of a bulb. Although there is no specific teaching of the inner and outer surfaces of the dispenser having a specific shape and/or differing shapes, the courts held In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that a change in shape is matter of choice in which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus was significant.
Claim(s) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tobin et al (USP 3,792,699) in view of Hiemer et al (US 2021/0220868 A1).
Refer above for the disclosure of Tobin.
With respect to claim 5 Tobin fails to disclose that the plastic sleeve has a ramp-like projection on the interior, the projection interacting in such a manner with the ampoule upon actuation of the activation element that a tip of the ampoule is broken off.
Hiemer teaches an applicator 1 comprising an outer sleeve 10 having a cylindrical inner surface and a receiving space for a flowable substance to be applied and an inner sleeve 15 which can be displaced in the outer sleeve 10 and in which a frangible ampule 16 containing the flowable substance is disposed and which has an opening 20 connecting an interior of the inner sleeve to the receiving space of the outer sleeve and an activation means 21 upon whose activation the ampule breaks (See abstract and Para. 0044-0045). Push-button-like activation means 21 has a ramp 24 on its inner side, ramp 24 ascending on tip 18 of ampule 16 upon activation of activation means 21 and snapping tip 18 off. Moreover, a ramp 25 is formed adjacent to opening 20 in inner sleeve 15, ramp 25 interacting with tip 17 of ampule 16 and serving to snap off tip 17 and opening ampule 16 upon activation of activation means 21 and opening ampule 16. Furthermore, inner sleeve 15 comprises an interior 26 which receives ampule 16 and is connected to a receiving space 28 via opening 20, receiving space 28 being disposed in outer sleeve 10 between the front side of inner sleeve 15 or check valve 13 on the one hand and discharge opening 11 on the other hand (See Para. 0047). The object of the disclosure is to create an applicator by means of which the flowable substance contained in the frangible ampule can be conveyed to a discharge opening of the applicator in a defined manner (See Para. 0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the ampoule and plastic sleeve of Tobin with the ampoule and push-button means of Hiemer in order to create a test arrangement by means of which the flowable substance contained in the frangible ampoule can be conveyed to a discharge opening of the apparatus in a defined manner (See Para. 0004 of Hiemer).
With respect to claim 16 Tobin fails to disclose that the actuation element comprises an actuation button, which is pressed into the plastic sleeve and has a plane ramp on its interior, the ramp interacting with a tip of the ampoule.
Hiemer teaches an applicator 1 comprising an outer sleeve 10 having a cylindrical inner surface and a receiving space for a flowable substance to be applied and an inner sleeve 15 which can be displaced in the outer sleeve 10 and in which a frangible ampule 16 containing the flowable substance is disposed and which has an opening 20 connecting an interior of the inner sleeve to the receiving space of the outer sleeve and an activation means 21 upon whose activation the ampule breaks (See abstract and Para. 0044-0045). Push-button-like activation means 21 has a ramp 24 on its inner side, ramp 24 ascending on tip 18 of ampule 16 upon activation of activation means 21 and snapping tip 18 off. Moreover, a ramp 25 is formed adjacent to opening 20 in inner sleeve 15, ramp 25 interacting with tip 17 of ampule 16 and serving to snap off tip 17 and opening ampule 16 upon activation of activation means 21 and opening ampule 16. Furthermore, inner sleeve 15 comprises an interior 26 which receives ampule 16 and is connected to a receiving space 28 via opening 20, receiving space 28 being disposed in outer sleeve 10 between the front side of inner sleeve 15 or check valve 13 on the one hand and discharge opening 11 on the other hand (See Para. 0047). The object of the disclosure is to create an applicator by means of which the flowable substance contained in the frangible ampule can be conveyed to a discharge opening of the applicator in a defined manner (See Para. 0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the ampoule and plastic sleeve of Tobin with the ampoule and push-button means of Hiemer in order to create a test arrangement by means of which the flowable substance contained in the frangible ampoule can be conveyed to a discharge opening of the apparatus in a defined manner (See Para. 0004 of Hiemer).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tobin et al (USP 3,792,699) in view of Niedbala et al (US 2003/0064526 A1).
Refer above for the disclosure of Tobin.
With respect to claim 17 Tobin fails to disclose that the container is fastened on a test cassette.
Niedbala teaches a collector 10 and a cassette 100, as shown in its preferred embodiment in FIGS. 1-11. Collector 10 is of the type that is used to collect a liquid sample (hereinafter `sample`) such as oral fluid, blood, urine, or other liquid samples which may or may not be otherwise treated prior to being absorbed by collector 10. Collector 10 can be used alone or in combination with a cassette 100. Likewise, cassette 100 can be used with other sample collection and transfer devices. When used in combination, collector 10 is inserted into cassette 100 and the sample is transferred from the collector 10 to the cassette 100. Cassette 100 preferably includes a lateral flow test device that has the ability to detect target analytes in the fluid sample. The results from the lateral flow test may be identified either by the naked eye or by using an instrument. In the preferred embodiment, results are detected by using an instrument (See Par. 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Tobin such that it is adaptable to be fastened to a cassette, such as the configuration taught by Niedbala, in order to allow for the detection of target analytes in a fluid sample (See Para. 0033 of Niedbala).
With respect to claim 18, the combination of Tobin and Niedbala teaches that the test cassette is equipped with a test strip (See Para. 0047 of Niedbala for discussion of an assay strip disposed in the cassette 100).
Allowable Subject Matter
Claims 13, 19, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest cited prior art of reference fails to disclose or fairly teach:
That the container has a stop on its circumference which interacts with the apron of the plastic sleeve (claim 13);
A valve which control liquid flow between the mixing space of the container and a test space of the test cassette, and which has a manually pressable actuation button (claim 19); and
A container having a reference liquid is disposed on the test cassette (claim 20).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 September 4, 2026
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